Welcome to the Process Engineering and Formulation Focus Group
The group focuses on drug product formulation and manufacturing processes; including solid, semi-solid and liquid dosage forms. Established processing operations (e.g. mixing, comminution, granulation and compaction) and new formulation and process technology approaches are in scope. Further interests include Quality by Design strategies, PAT applications, and Quality Risk assessments that demonstrate product and process understanding to the regulatory authorities.
What We Do
The Focus Group steering committee has representation from industrial scientists in a number of large pharma companies including Pfizer, GSK, AstraZeneca and Bristol-Myers Squibb; academics from De Montfort and Leeds Universities; and specialist technology companies such as Colorcon. Focus Group members are participants in a number of cross-academia and cross-industry collaborations.
Examples include:
- ADDoPT (Advanced Digital Design of Pharmaceutical Technologies)
- Manufacturing Classification System (MCS) working party.
Take a look at the papers published:
- Leane M, Pitt KG, Reynolds G. A Proposal for a Drug Product Manufacturing Classification System (MCS) for Oral Solid Dosage Forms. Pharmaceutical Development and Technology 2015; 20: 12-21. Read here.
- Leane M, Pitt KG, Reynolds GK, Dawson N, Ziegler I, Szepes A, Crean AM , Agnol RD. Manufacturing Classification System in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations, case studies from industry and considerations for continuous processing Pharmaceutical Development and Technology 2018. Read here.
- Leane M, Pitt KG, Reynolds GK, Tantuccio A. et al Ten years of the manufacturing classification system: a review of literature applications and an extension of the framework to continuous manufacture. Pharmaceutical Development and Technology 2024; 29(5), 395–414. Read here.
The Focus Group will promote scientific education and training in the field of PEPF to meet the needs of scientists and engineers working in both industrial and academic sectors. The Focus Group will provide an active community of practice for those interested in the science of formulation and process development, and through this network seek to develop opportunities for cross-sector pre-competitive collaboration. The Focus Group will contribute to the scientific programme for the annual APS PharmSci meeting and organise additional symposia to promote awareness of innovative approaches for formulation and process development.
What We’ve Done
We’ve run many successful symposia over the years, both stand-alone and within the APS PharmSci Conference. As PEPF is so broad, we tend to focus on our 3 hot topic areas as these are key areas of interest at the current time.
March 2019-We held an event-Additive Manufacturing Symposium-current developments in additive manufacturing of oral dosage forms.
Hot Scientific Topics
- Science of Scale
- Flexible and adaptive manufacture including continuous
- Manufacturing Classification system
Meet the Group
Dr Stuart Charlton
Associate Scientific Director,
Bristol-Myers Squibb
click to read bio
Dr Ranjit Dhenge
Platform and Process Engineering Team Leader, GlaxoSmithKline
click to read bio
why you should get involved?
We aim to facilitate discussion and exchange of information both within pharmaceutical companies and industry sectors involved
in similar or new types of process technologies, e.g. ceramics, foods, paints, agrochemicals, electronics, automobile, fine chemicals,
household products.
We also provide a link between Industry and Academia; and foster interaction with other Focus groups. We plan to organise
symposia once or twice a year.
If you have an interest in the science of formulation and process design, and would like to contribute to the planning and delivery of
our meetings, then get in touch. It is a great opportunity to network with scientists who share your interests.